Field of the Invention
The present invention relates to an adaptor for coupling to a medical container such as a vial containing a pharmaceutical product, such as a vaccine, said adaptor allowing for multiple aseptic needle piercings with an injection device to be filled with part of the product contained in the medical container.
Description of Related Art
In this application, the distal end of a component or apparatus means the end furthest from the hand of the user and the proximal end means the end closest to the hand of the user, with reference to the injection device intended to be used with said component or apparatus. As such, in this application, the distal direction is the direction of injection with reference to the injection device, and the proximal direction is the opposite direction, i.e. the direction of the transfer of the product from the vial to the injection device. In the present application, “longitudinal” means aligned on the axis defining the distal and proximal directions as defined above.
One of the ways to improve health is to immunize entire populations against a number of diseases. To date, injection administration is the most common method of administering vaccines.
Each year, numerous drugs, for example vaccines, are prepared by healthcare institutions for distribution throughout many parts of the world, including those locations in cities, villages or remote area.
From a supply chain perspective, an efficient vaccine packaging is a multidose container such as a multidose vial, that is to say, a vial that may contain up to 10, 100 or 1000 doses of vaccine, one dose being intended for one patient. These vials are usually closed by a septum. In preparation of an injection of a vaccine, the user pierces the septum of the vial with the needle of an empty syringe, the user then fills the syringe with one dose of vaccine and proceeds to the injection of the vaccine to the patient.
In locations where it is difficult to maintain favorable hygienic conditions such as remote locations which are far from towns and from hospital facilities, the multidose vials may be handled and manipulated at ambiant air. In such cases, the septum of the vial may be contaminated either by the ambiant air, or, each time a dose of vaccine is removed, by the needle of the empty syringe used.
In addition, in regions where there is limited or potentially no supply of energy to power cooling equipment, such as a refrigerator, the multidose vials may be maintained in cold conditions by simple contact with ice packs. As time goes by, part of the ice may melt and turn into water, and the septum of the multidose vials may be in contact with such water that may contaminate the septum of the vial.
It may then be the case that a multidose medical container, such as, for example, a 10-dose medical container, is opened and that only three doses are used, for vaccinating three patients only. The remaining content of the medical container is then wasted because it is not administered in a sufficiently short time after opening of the medical container and the vaccine or drug sterility cannot be guaranteed.
Vaccination campaigns can therefore be made difficult in some regions and a significant proportion of vaccines may be wasted. This has an unacceptable cost to the health organizations in charge of immunization campaigns. In addition, it may happen that in case of vaccination campaigns, or pandemic, hundreds of patients need to be vaccinated in a very short time which complicates the management of product doses and the patient track record.
As such, multidose vials imply that the septum of the vial be pierced successively a high number of times, namely as many as the number of doses present in the vial. In order to ensure safe injections, the sterility of the vial content and the integrity of its septum should be maintained during the whole time the vial is used.
Successive piercings of the same septum area could lead to the contamination of the vial interior by introducing contaminants inside the vial from the first piercing of the septum. Moreover, different piercings can form a definitive hole through the vial septum, the septum being incapable of resealing after several piercings in the same area and therefore losing its isolating properties that ensures the integrity of the vial content from the outside environment.
Therefore, it would be desirable to provide a device that would allow several successive piercings of a multidose vial septum and that would guaranty that said piercings be carried out in aseptic conditions. In particular, it would be desirable to provide a device that would guaranty that each new piercing be completed in an area of the septum that has not yet been pierced during the previous withdrawals of doses of product.